Asthma in ChildrenNCT06141616
Effects of Pulmonary Rehabilitation on Clinical Outcomes in Children With Asthma
A study testing Asthma Rehabilitation Program in people with Asthma in Children and Physical Inactivity, run by Universidade Norte do Paraná at 1 site in Brazil.
Trial summary
Although the practice of physical activity is recommended for children with asthma, the scientific literature available so far has focused mainly on improving functional capacity and quality of life. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Asthma in Children, Physical Inactivity
- What is being tested?
- Asthma Rehabilitation Program
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2023to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 6 and 12 years old;
- Clinical diagnosis of asthma, established according to the criteria of the Global Initiative for Asthma (GINA);
- Absence of other lung diseases or signs and symptoms of other lung diseases;
- Absence of cognitive changes;
- Absence of signs and symptoms of gastroesophageal reflux disease and dysphagia;
- Clinical stability according to the criteria of the Global Initiative for Asthma (GINA);
Who cannot join
- Desire of the patient and/or the patient's family to discontinue participation in the study for any reason;
- Present some new limitations that may interfere with functionality;
- Comorbidities that prevent or contraindicate the performance of the proposed interventions.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Centro de Pesquisa e Pós Graduação na Unopar
Londrina, Paraná, 86041-14
About this study
Official title: Effects of Pulmonary Rehabilitation on Activities of Daily Living, Physical Activities of Daily Living and Other Clinical Outcomes in Children With Asthma: a Randomized Clinical Trial
Although the practice of physical activity is recommended for children with asthma, the scientific literature available so far has focused mainly on improving functional capacity and quality of life. However, the effects of pulmonary rehabilitation in this population, especially in improving the level of physical activity in daily living (PADL) and activities of daily living (ADLs) have not yet been investigated in depth. Therefore, the objective of this study is to verify the effects of pulmonary rehabilitation on PADL, ADL, and other clinical outcomes of children with asthma. For this, a randomized clinical trial will be carried out that will have 2 groups: the control group (CG), which will receive only educational sessions, and the intervention group (IG) which will participate in a pulmonary rehabilitation program with supervised aerobic training performed three times a week with sessions of 60 minutes each. The total duration of interventions in both groups will be 12 weeks. The primary outcomes of this study are PADL (assessed using a physical activity monitor - Actigraph) and ADL; however, the following will also be evaluated: lung function, functional capacity, asthma control, and quality of life. We hypothesized that the performance of regular physical activity and supervised physical exercise by individuals with asthma could positively impact health outcomes with better control of asthma symptoms, better performance in ADL and PADL, and better quality of life.
- Conditions
- Asthma in Children, Physical Inactivity
- Being tested
- Asthma Rehabilitation Program
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asthma Rehabilitation ProgramOther
The group will receive free physiotherapy treatment with aerobic exercises, 3x/week, 60 minutes a day, lasting 3 months, in addition to educational sessions in a playful way.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Sham comparator | Sessions once a week, covering information about the pathophysiology of asthma, medication instructions, self-monitoring techniques, environmental control techniques, and prevention strategies for children, adolescents, and families. They will also receive physical activity recommendations, as well as information about the importance and benefits of being physically active and maintaining a healthy lifestyle. The sessions will feature educational and playful videos, presentations, and participants will be able to clarify their doubts about the topic addressed. Receives: Other: Asthma Rehabilitation Program |
| Experimental group | Experimental | Rehabilitation program performed 3x/week. Each session will last 60 minutes, with a minimum interval of 24 hours, for a period of three months. The main focus of the intervention is aerobic training, which will be carried out in three stages, treadmill with a warm-up (10 minutes), load (20 minutes), and cool-down (5 minutes). With an initial intensity of 65% of the maximum load obtained in the incremental shuttle walk test (ISWT). The intensity will be gradually increased up to 115%, keeping dyspnea and fatigue values between 4 and 6, according to the modified Borg scale. In addition, we will do a circuit focused on aerobic activities, maintaining target heart rate during its performance for 20 minutes. When necessary, supplemental oxygen will be provided during training. Volunteers in this group will receive a bronchodilator dose before starting each day's session. This group will hold educational sessions as well. Receives: Other: Asthma Rehabilitation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
Number of steps per day, time spent (in minutes and percentage of the day) in light-intensity and moderate to vigorous physical activities, measured by a triaxial activity monitor.
Measured: 12 weeks from randomization
Sedentary behavior
Time spent (in minutes and percentage of the day) in sedentary activities, measured by a triaxial activity monitor.
Measured: 12 weeks from randomization
The activity of daily living
Time on a specific test to evaluate activities of daily living in children
Measured: 12 weeks from randomization
Secondary outcomes (12)
Initial assessment about general characteristics and health status
A questionnaire will be prepared to cover all these topics: age, weight, height, body mass index (BMI), history of prematurity, personal, family, and surgical history, in addition to comorbidities. These data will be used to characterize the sample and the questionnaire will be answered with the help of the family member.
Measured: 12 weeks from randomization
Pulmonary Function
Spirometry determining the forced expiratory volume in the first second (FEV1), forced vital capacity (FVC) and FEV1/ FVC index.
Measured: 12 weeks from randomization
Asthma Control
The asthma control questionnaire (ACT or ACT-C) will be applied according to the child's age, to determine if the asthma is controlled. The ACT consists of five questions. The score for each question varies between 1 and 5 points. The minimum score of the questionnaire is 5 points and the maximum score is 25 points. The ACT-C, which will be applied to children younger than 11 years and 12 months, consists of seven questions, four of them answered by the child and three by parents or guardians, with a minimum score of 0 and a maximum of 27.
Measured: 12 weeks from randomization
Exacerbation and medication diary
Diaries will be given to patients in which individuals with asthma or their guardians must record any asthma exacerbations, as well as the use of medications for the disease. Exacerbations will be defined as the use of oral corticosteroids due to worsening symptoms; the need for a doctor's appointment or emergency care due to worsening symptoms. These data may be used as confounding factors in the statistical analysis in case of eventual exacerbations and/or changes in medications during the intervention.
Measured: 12 weeks from randomization
Quality of life in asthma
The Pediatric Asthma Quality Of Life Questionnaire (PAQLq), consists of 23 questions divided into three domains: physical activity limitations, symptoms, and emotions. Responses will be measured on a 7-point scale, where 1 indicates maximum loss and 7 indicates no loss. This questionnaire has already been translated and validated for the Brazilian language, for the population of children and adolescents with asthma and the other questionnaire used to assess quality of life in children, the Pediatric Quality of Life (PedsQL), Structurally, it consists of 27 items divided into 8 subscales: pain and injuries, nausea, anxiety about the procedure, anxiety about the treatment, concerns, difficulties cognitive, perception of physical appearance, communication. The scale consists of 5 response options, like "Likert": "never", "rarely", "sometimes", "often", and "almost always" .
Measured: 12 weeks from randomization
Sleep assessment
Children's Sleep Habits Questionnaire (CSHQ) assesses parents' perception of their children's sleep during the previous week or, if not representative for some reason, during a more recent typical week. The frequency of sleep behaviors is rated on a three-point scale, such as "usually" (five to seven times a week, totaling three points), "sometimes" (two to four times a week, totaling two points), or " rarely" (0 to once a week, totaling one point).
Measured: 12 weeks from randomization
Parents' knowledge about the child's illness
Asthma Knowledge Questionnaire - Short form (AKQ) The scale contains 10 statements, and responses are given on a 5-point Likert scale, with responses ranging from "totally disagree" to "totally agree", ranging from 1 to 5 respectively. Negative items will be reverse-coded by subtracting the response value from 5. This implies that the correct answer is always "strongly agree" for all questions. The final score is the sum of all responses, ranging from 10 to 50, with higher scores indicating greater knowledge of asthma.
Measured: 12 weeks from randomization
Family Health Questionnaire
The purpose of this questionnaire is to obtain information about the health behavior of those responsible and the health behavior of the child. Answering the questionnaire will take about 45 minutes of the parents' time and will be applied while the child performs the functional tests.
Measured: 12 weeks from randomization
Report of performance in physical activities
Preschool-age Children's Physical Activity Questionnaire (Pre-PAQ) and Physical Activity Questionnaire for Children (PAQ-C) according to age.
Measured: 12 weeks from randomization
Motivation scale
A simple question based on the transtheoretical model of behavior change about self-reported motivation and physical activity behavior will be applied to children.
Measured: 12 weeks from randomization
Submaximal exercise capacity
To assess this outcome, the six-minute walk test (6MWT) and sit-to-stand (STS) will be used. The 6MWT will be performed according to international standards. Individuals will be instructed to cover the longest possible distance in 6 minutes in a 30-meter-long flat corridor, without running. Two tests will be performed with a minimum interval of 30 minutes. Sit-to-stand: The test will be performed using a chair that ensures 90 degrees of hip, knee, and ankle flexion. When individuals are instructed with the word "go", they will have to get up immediately without delay and sit down again, repeating the procedure as many times as they can within 1 minute, the number of repetitions will be counted.
Measured: 12 weeks from randomization
Maximal exercise capacity
Incremental Shuttle Walk Test (ISWT): The ISWT will be performed in a 10 m-long corridor as per the original description. It is a test externally cadenced by a sound signal, in which the speed increases every minute, ranging from 1.79 to 10.2 km/h. The total test time and the distance covered by the patient will be recorded at the end of the test
Measured: 12 weeks from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study startDec 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Norte do Paraná
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karina Furlanetto, Universidade Norte do Paraná
- Investigators
- Vitória Puzzi, Msc, Principal investigator, Universidade Norte do Paraná
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141616
- Sponsor's protocol ID
- PuzziVC_PhD_FurlanettoKC
- Status last verified
- Nov 2023
- First submitted
- 11 Nov 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pulmonary Rehabilitation on Activities of Daily Living, Physical Activities of Daily Living and Other Clinical Outcomes in Children With Asthma: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06141616
- Acronym / sponsor ID
- PuzziVC_PhD_FurlanettoKC
- Conditions
- Asthma in Children, Physical Inactivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidade Norte do ParanáUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 21 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although the practice of physical activity is recommended for children with asthma, the scientific literature available so far has focused mainly on improving functional capacity and quality of life. However, the effects of pulmonary rehabilitation in this population, especially in improving the level of physical activity in daily living (PADL) and activities of daily living (ADLs) have not yet been investigated in depth. Therefore, the objective of this study is to verify the effects of pulmonary rehabilitation on PADL, ADL, and other clinical outcomes of children with asthma. For this, a randomized clinical trial will be carried out that will have 2 groups: the control group (CG), which will receive only educational sessions, and the intervention group (IG) which will participate in a pulmonary rehabilitation program with supervised aerobic training performed three times a week with sessions of 60 minutes each. The total duration of interventions in both groups will be 12 weeks. The primary outcomes of this study are PADL (assessed using a physical activity monitor - Actigraph) and ADL; however, the following will also be evaluated: lung function, functional capacity, asthma control, and quality of life. We hypothesized that the performance of regular physical activity and supervised physical exercise by individuals with asthma could positively impact health outcomes with better control of asthma symptoms, better performance in ADL and PADL, and better quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Sham comparator | Other: Asthma Rehabilitation ProgramSessions once a week, covering information about the pathophysiology of asthma, medication instructions, self-monitoring techniques, environmental control techniques, and prevention strategies for children, adolescents, and families. They will also receive physical activity recommendations, as well as information about the importance and benefits of being physically active and maintaining a healthy lifestyle. The sessions will feature educational and playful videos, presentations, and participants will be able to clarify their doubts about the topic addressed. |
| Experimental group | Experimental | Other: Asthma Rehabilitation ProgramRehabilitation program performed 3x/week. Each session will last 60 minutes, with a minimum interval of 24 hours, for a period of three months. The main focus of the intervention is aerobic training, which will be carried out in three stages, treadmill with a warm-up (10 minutes), load (20 minutes), and cool-down (5 minutes). With an initial intensity of 65% of the maximum load obtained in the incremental shuttle walk test (ISWT). The intensity will be gradually increased up to 115%, keeping dyspnea and fatigue values between 4 and 6, according to the modified Borg scale. In addition, we will do a circuit focused on aerobic activities, maintaining target heart rate during its performance for 20 minutes. When necessary, supplemental oxygen will be provided during training. Volunteers in this group will receive a bronchodilator dose before starting each day's session. This group will hold educational sessions as well. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age between 6 and 12 years old;
- Clinical diagnosis of asthma, established according to the criteria of the Global Initiative for Asthma (GINA);
- Absence of other lung diseases or signs and symptoms of other lung diseases;
- Absence of cognitive changes;
- Absence of signs and symptoms of gastroesophageal reflux disease and dysphagia;
Key exclusion criteria (3 listed)
- Desire of the patient and/or the patient's family to discontinue participation in the study for any reason;
- Present some new limitations that may interfere with functionality;
- Comorbidities that prevent or contraindicate the performance of the proposed interventions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Asthma Rehabilitation ProgramThe group will receive free physiotherapy treatment with aerobic exercises, 3x/week, 60 minutes a day, lasting 3 months, in addition to educational sessions in a playful way. | Other | Control group, Experimental group |
Primary outcome
Physical activity
Time frame: 12 weeks from randomization
Number of steps per day, time spent (in minutes and percentage of the day) in light-intensity and moderate to vigorous physical activities, measured by a triaxial activity monitor.
Sedentary behavior
Time frame: 12 weeks from randomization
Time spent (in minutes and percentage of the day) in sedentary activities, measured by a triaxial activity monitor.
The activity of daily living
Time frame: 12 weeks from randomization
Time on a specific test to evaluate activities of daily living in children
12 secondary outcomes
Initial assessment about general characteristics and health status
Time frame: 12 weeks from randomization
Pulmonary Function
Time frame: 12 weeks from randomization
Asthma Control
Time frame: 12 weeks from randomization
Exacerbation and medication diary
Time frame: 12 weeks from randomization
Quality of life in asthma
Time frame: 12 weeks from randomization
Sleep assessment
Time frame: 12 weeks from randomization
Parents' knowledge about the child's illness
Time frame: 12 weeks from randomization
Family Health Questionnaire
Time frame: 12 weeks from randomization
Report of performance in physical activities
Time frame: 12 weeks from randomization
Motivation scale
Time frame: 12 weeks from randomization
Submaximal exercise capacity
Time frame: 12 weeks from randomization
Maximal exercise capacity
Time frame: 12 weeks from randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vitória Puzzi, Msc principal investigator
Universidade Norte do Paraná
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Asthma Rehabilitation Program in people with Asthma in Children and Physical Inactivity, run by Universidade Norte do Paraná at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karina Furlanetto, PhD (+55 43 991144621, ka_furlanetto@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity (time frame: 12 weeks from randomization). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.